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The 340B Drug Pricing Program: State Optimization of 340B
Promoting Integrity, Access, & Value Lisa Scholz, PharmD, MBA
Senior Director, HRSA PSSCJuly 23, 2008 NCSL New Orleans, LA
OFFICE OFPHARMACY AFFAIRS
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Learning Objectives
Intent of the program
1
340B Pricing
2Entity
location, eligibility and enrollment
3
Program requirements
and prohibitions
4Program
regulation, guidanceand policy
5
Implementation Options
6
Patient Safety and Clinical Pharmacy
Collaborative
7
State Optimization
8
Available resources
9
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Intent of the 340B Program
Patients340B Eligible Entities
Safety net providers
SAVINGS
Improve financial stability
Stretch dollars to serve
vulnerable patients
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The 340B Price
Centers for Medicare and Medicaid Services
Drug Manufacturers
The 340B price is actually a “ceiling” price
25-50%of the average wholesale price
DRUG PRICING PROGRAM
340B
OFFICE OFPHARMACY AFFAIRS
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The 340B Price
Pharmacy services in HRSA programs & safety-net partners are growing rapidly
$5,000,000,000
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The 340B Price Financial Savings
Heinz Foundation Report (Rhode Island)• Comprehensive statewide evaluation
• Net savings estimated at $2M first year
www.hfp.heinz.org/pdfs/ri340b.pdf
Wellpartnertm
Analysis – California Medicaid• Adjusted dispensing fee
• 12.2% savings below net Medicaid price
www.nlarx.org/policy/pdfs/Oregon340BPricing_analysis.pdf
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340B Entity Locations by State
584
264
62
1245
771
358
334332253567
107
13,139Total Entities
86 HI
71AK410
233
211
109273
57
35
31
109
175
228
46
543
212390789
404346
47
32972
118118
132504
77
481
303
255 MD
112 CT
182
37 DC
42 NH45 VT
185 NJ38 DE
45 RI
285 MA
10 VI
82 PR
American Samoa 1 FS of Micronesia 2 Guam 6 Marshall Islands 4 Palau 1
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Growth of 340B Program by Agency
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340B Enrollment Procedure
ELIGIBLE ENTITIES MUST ENROLL
FORMS AND ENROLLMENT INFORMATION
ADMISSION PROCESS
Click on “Legal Resources”
http://www.hrsa.gov/opa
Submit completed form to OPA
OPA verifies eligibility
Participation begins next quarterly database update
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340B Statute Requirements & Prohibitions
Audit Resell/Transfer
Prohibition
Duplicate Discount
Prohibition
Prime Vendor DisproportionateShare Hospital
GPO Exclusion
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340B Regulation and Policy
Federal Register Notice publication
www.hrsa.gov/opa
OFFICE OFPHARMACY AFFAIRS
Interpreting the legislation and
implementing the 340B Program
may at times be a challenge
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340B Regulation and Policy
Federal Register Notice publication
www.hrsa.gov/opa/federalregister.htm
OFFICE OFPHARMACY AFFAIRS
Definition of a Patient
entity has established relationship & maintains records of care
1
3 patient receives health care consistent with range of services from the covered entity
2 patient receives health care services from health care professional employed/contracted with entity
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Proposed Guidance: 3 Federal Register Notices
Definition of Patient –72 FR 1543• Clarifies previous FR Notice of October 1996
• Provides specific guidance and examples
• A clear and enforceable definition to help ensure against diversion and support 340B program integrity
Contract Pharmacy –72 FR 1540 • Updates previous FR Notice of August,1996
• Builds upon experience with Demonstration Projects
• Incorporates Multiple Pharmacies as standard option
Status• Comment Period 1/12/07 – 03/13/07
• Comments being reviewed and final publication being developed
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Proposed Guidance: 3 Federal Register Notices, continuedChildren’s Hospitals• Clarifies that children’s hospitals are subject to the same 340B
responsibilities as other covered entities • Describes application procedures for children’s hospitals• Reaffirms drug manufacturers’ responsibility to furnish
discounts under Pharmaceutical Pricing Agreement (PPA).
Status • Published in Federal Register July 9, 2007 with 60 day
comment period• Comments being reviewed and final publication being
developed
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340B Implementation Options
340B Eligible Entities
Alternative Methods Demonstration Projects
www.hrsa.gov/opa/alternativemethods.htm
OFFICE OFPHARMACY AFFAIRS
Entities expressed interest in new ways to increase access to 340B drugs
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Call To Action: Institute of Medicine on Patient Safety
Medication Errors are Most Common Injure 1.5 Million People AnnuallyCost Billions Annually
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“…for every dollar spent on ambulatory medications, another dollar is spent to treat new health problems caused by the medication.”
Call To Action: Institute of Medicine on Patient Safety
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HRSA Patient Safety & Clinical Pharmacy Services Collaborative: Goals
• Improve Health Outcomes
• Increase Cost-Effective Clinical Pharmacy Services
• Enhance Patient Safety
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HRSA Patient Safety & Clinical Pharmacy Collaborative: Update
•34 High Performer Site Visits: Dec 07 to April 08
•Change Package: April 2008
•State Leadership Meeting: May 1, 2008
•Teams Identified – July 1st
•Team pre-work: July 16th
•Learning Session 1: August 14-15th
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HRSA Patient Safety & Clinical Pharmacy Services Collaborative: Teams
Total Team Submissions:
91
AK 1
AL 1
AZ 1
CA 3CO 2
CT 1MA 7
FL 2
GA 1
HI 2
IA 3
ID 3
IN 1
IL 3 KY 3
LA 5
MD 4DC 1
ME 1
MI 2
MN 1
MO 2
MT 1
NC 2
ND 2
NJ 5
NM 2
NY 3
OH 5
OR 2
PA 2
PR 2
SC 2TX 2
TN 2
UT 1 VA 4
VT 1WA 1
WY 1
WV 1
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Patient Safety & Clinical Pharmacy Collaborative: Our Partners
ASHP CMS AHRQAPhA NACDS Joint CommissionNRHA IHI Heinz FoundationANA ISMP NACHCUSP PQA VAFDA CDC AANPNASTAD State PCA’sApexus/Prime Vendor Program
…and Many Others
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• Drug formulary management• Patient-specific counseling, education and
monitoring• Medication Therapy Management• Medication education for providers• Health promotion seminars• Collaborative disease management• Provide immunizations• Perform drug utilization review• Safe Medication Use
Patient Safety & Clinical Pharmacy Collaborative: Pharmacist Role
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State Optimization of 340B:Reasons to Consider
•Increased prescription drug utilization•Increased numbers of uninsured and underinsured•Skyrocketing health care costs•Dual eligible transition to Medicare•Growth in 340B program utilization, value and support
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State Optimization of 340B:Challenges to Address
•Underutilization by covered-entities•Procurement policy restrictions•Need for program adherence •Provider relationships/collaboration•Continuity of Care•Funding•Evaluation methods•On-going administration
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State Optimization of 340B:Key Implementation Steps
Step 1 – Evaluate opportunity and potential impact from both a financial and system service delivery perspective.
Step 2 – Identify and resolve regulatory barriers to implementation.
Step 3 – Implement measures to facilitate program participation and utilization of 340B resources.
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340B Program Resources:
Integrity Access Value
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Integrity
Integrity Resource:
Develops innovative pharmacy
service models and supports
technical assistance
Serves as Federal resource
for pharmacy practice
Administers 340B program
• Access to affordable drugs
• Application of “best practices”
Office of Pharmacy Affairs (OPA)
• Efficient pharmacy management
• Systems to improve patient outcome
Importance of Comprehensive Pharmacy Services
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Access Resource:
Helps eligible entities,
implement and optimize the
340B program
Providesinformation resources,
policy analysis &education
Access
Pharmacy Services Support Center (PSSC)
• Call Center
• Web Site
• Outreach Program
• Pharmacy Technical Assistance Program
Operates
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340B PSSC Inquiries by State:
82
19
13
171
109
62
60332064
28
1767Total Entities*
18 HI
11AK70
38
30
1324
7
9
2
19
19
28
46
77
15 2829
3434
18
2321
2022
2388
8
52
74
40 MD
24 CT
12
30 DC
6 NH7 VT
46 NJ3 DE
5 RI
35 MA
2 VI
15 PR
American Samoa 0 FS of Micronesia 0 Guam 0 Marshall Islands 0 Palau 0
*October 2007 to present
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Value Resource:
Offers value added products
and services
Offered at no cost to entity
Negotiates sub-ceiling prices
Helps with access to drug
distribution solutions
Value
Prime Vendor Program (PVP)
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How to Access Resources:
www.hrsa.gov/opa
pssc.aphanet.org
1-800-628-6297
www.340bpvp.com
1-888-340-2787
OFFICE OFPHARMACY AFFAIRS
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Thank You!
Lisa Scholz, PharmD, MBA
Senior Director,PSSC
[email protected] 1-800-628-6297
Office of Pharmacy Affairs
